Senior Manager, Statistical Programming

EDETEK

3d

About The Position

The Senior Manager of Statistical Programming remains hands-on with the daily activities of a Statistical Programmer or Senior Statistical Programmer while leading assigned programming projects. The role produces and validates clinical study reporting outputs and datasets, documents programs and data, and supports data transfers. In addition, the Senior Manager communicates with clients about timelines and deliverables, assigns work and resolves technical problems, trains junior team members, helps maintain secure SAS-server access with IT, and works with Quality Assurance on procedures and CONFORM module testing and validation.

The role requires strong, advanced SAS skills and knowledge of clinical trials and drug development, along with effective communication, attention to detail, prioritization, collaboration, independence, and adaptability. A master’s degree or above in Biostatistics, Computer Science, Mathematics, or a combination of education and relevant industry experience is required. At least two years of clinical SAS programming experience is specified for the manager position. The position may be onsite, hybrid, or remote within the United States. Some travel (5%) may be required, potentially over weekends. The company is open to considering candidates at Senior Manager, Associate Director, Director, or above, depending on experience and qualifications.

Requirements

• Ability to communicate effectively in English, both verbally and in writing.
• Ability to learn quickly and pay attention to detail.
• Ability to manage multiple tasks and projects, prioritize and execute effectively, and deliver quality work on time.
• Ability to work collaboratively and productively across diverse organizational structures and with dynamic clients.
• Ability to work independently, take ownership, and strive for quality and efficiency.
• Ability to work positively in a continually changing environment.
• Solid or advanced SAS skills and understanding of standardization in data, programming, and statistical reporting of trial results and its implications for drug development.
• Master’s degree or above in Biostatistics, Computer Science, or Mathematics, or a combination of education and relevant industry experience.
• Strong SAS programming skills and good knowledge or experience of clinical trials and drug development.
• At least two years of clinical SAS programming experience for the manager position.

Responsibilities

• Program tables, listings, and graphs required for assigned clinical study reports.
• Act as lead programmer for assigned projects.
• Program customized data displays, including listings, summary tables, and routine graphics, according to the approved statistical analysis plan and shell displays.
• Write code using Base SAS programs, SAS procedures, or standardized macros.
• Review protocols, statistical analysis plans, shells, and templates to understand data structure and content.
• Perform data checks to ensure the integrity and correctness of data displays.
• Prepare program documentation and documentation describing datasets, variables, derived variables, and the overall project.
• Create SAS datasets of clinical data from clinical databases, as well as status and efficacy datasets.
• Create project-specific macros and formats.
• Load client data from other platforms and software packages.
• Prepare data for clients and other external transfers and data imports.
• Communicate with clients to set and manage project timelines and deliverables.
• Assign projects to the team and solve problems and technical difficulties.
• Train junior team members on industry regulations, standards, and internal tools.
• Work with IT to set up and maintain a secure environment with proper access control on SAS servers.
• Work with Quality Assurance on drafting and revising Standard Operating Procedures and testing and validating CONFORM modules.

Benefits

• Choice of comprehensive medical, vision, and dental insurance plans for U.S. employees.
• Paid vacation time and sick days.
• Corporate holidays annually.
• Participation in the 401K Plan.
• Perks and discount programs for AAA, wholesale, insurance, prescription drugs, fitness, pets, entertainment, and other offerings.
• Health Advocate and Employee Assistance Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior